Kornimate/medical-research-clean huggingface dataset:
study to evaluate the efficacy/safety of ipi-549 in combination with nivolumab in patients with advanced urothelial carcinoma (mario-275)

Conditions: Bladder Cancer; Urothelial Carcinoma; Solid Tumor; Advanced Cancer

Summary: the purpose of this study is to measure the effect of ipi-549 in combination with nivolumab when compared to nivolumab monotherapy in advanced urothelial cancer patients.

study ipi-549-02 is a multi-national, prospective, randomized, active-control phase ii trial to evaluate the efficacy and safety of ipi 549 administered in combination with nivolumab compared to nivolumab monotherapy. the study will enroll approximately 160 checkpoint-naïve, advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy. patients will be randomized 2:1 to receive intravenous (iv) nivolumab 480 mg every 4 weeks (q4w) in combination with oral (po) ipi 549 40 mg once daily (qd) or iv nivolumab 480 mg q4w in combination with placebo po qd. eligible patients who have confirmed progression of disease during treatment with nivolumab monotherapy may crossover to the combination treatment arm.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra * measurable disease by ct or mri as defined by recist v1.1 * disease progression or recurrence after treatment: * i) with at least 1 platinum-based chemotherapy regimen for the treatment of metastatic (stage iv) or locally advanced unresectable disease; or * ii) with disease recurrence within 1 year of completing a platinum-based neoadjuvant or adjuvant therapy * subject that have received more than 2 prior lines of chemotherapy must not have liver metastases * tumor tissues (archived or new biopsy) must be provided for biomarker analysis * eastern cooperative oncology group (ecog) performance status ≤1 * blood sample must be provided for mmdsc levels for randomization into the study exclusion criteria: * active brain metastases or leptomeningeal metastases * any serious or uncontrolled medical disorder that may interfere with study treatment/interpretation * prior malignancy active within the previous 3 years except for local or organ confined early stage cancer that has been apparently cured * active, known, or suspected autoimmune disease * a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 day of study drug administration * prior therapy with anti-tumor vaccines, any t cell co-stimulation or checkpoint pathways, or ipi-549 * prior surgery or gastrointestinal dysfunction that may affect drug absorption * past medical history of interstitial lung disease * history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control * positive test for hepatitis b, c or hiv * dependent on continuous supplemental oxygen

Keywords: eganelisib ipi-549
effect of udenafil on spermatogenesis

Conditions: Spermatogenesis; Erectile Dysfunction

Summary: study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects on semen characteristics.

safety study in male subjects with no or mild ed (erectile dysfunction)

Eligibility criteria:
inclusion criteria: * no or mild ed (erectile dysfunction) willing \& able to provide 2 semen samples without the use of pde-5 inhibitor or other excluded medication or devices on 2 separate days during screening and at weeks 12 \& 26 * bmi (body mass index) between 19 and 31 kilogram/meter squared exclusion criteria: * new onset coronary artery disease within last 3 months, history of myocardial infarction or cardiac surgical procedure within last 6 months or sudden cardiac arrest * nitrate medications for angina pectoris * used of anti-arrhythmic drug treatment or device * congestive heart failure * uncontrolled diabetes * stroke or transient ischemic attack (tia) within last 6 months * bleeding disorder or history of gi bleeding within last 12 months * cancer chemotherapy * history of alcohol or drug abuse

Keywords: semen characteristics erectile dysfunction
prevention of seasonal affective disorder

Conditions: Seasonal Affective Disorder

Summary: this is a placebo controlled study evaluating the effectiveness of medication in preventing depressive episodes in subjects with a history of seasonal affective disorder (sad).


Eligibility criteria:
inclusion criteria: * patient has a history of major depressive disorder (mdd) with a seasonal pattern. exclusion criteria: * patient has a current or past history of seizure disorder or brain injury. * patient has a history or current diagnosis of anorexia nervosa or bulimia. * patient has recurrent summer depression more frequently than winter depression. * patient has primary diagnosis of panic disorder, obsessive compulsive disorder (ocd), posttraumatic stress disorder (ptsd), acute distress disorder, bipolar ii disorder or other psychotic disorders. * patient has initiated psychotherapy within the last 3 months.

Keywords: seasonal depression winter blues winter depression
safety and efficacy study of the venous window needle guide to access arteriovenous (av)fistulae

Conditions: End Stage Renal Disease; AV Fistula; Kidney Failure

Summary: the save study will evaluate the safety and efficacy of the venous window needle guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.


Eligibility criteria:
inclusion criteria: * deep, uncannulatable, upper extremity arteriovenous fistula * minimum arteriovenous fistula flow 400 ml/min * one year life expectancy exclusion criteria: * non-transposed basilic or brachial vein arteriovenous fistula * history of peripheral vascular disease * history of cardiovascular disease * history of cerebral vascular disease

Keywords: end stage renal disease hemodialysis av fistula kidney failure
study to ono-4538 in patients with rhabdoid tumor

Conditions: Rhabdoid Tumor

Summary: investigate the efficacy and safety of ono-4538 for the treatment of rhabdoid tumors


Eligibility criteria:
inclusion criteria: 1. gender: not specified 2. age (at the time of consent): 1 year or older 3. patients who are refractory or intolerant to one or more regimens of chemotherapy for rhabdoid tumors 4. patients with advanced or recurrent rhabdoid tumors not eligible for curative resection exclusion criteria: 1. patients with a history of active concurrent malignancy or complications 2. patients with spinal lesions expected to require radiation therapy or surgical intervention during the trial period 3. patients with concomitant central nervous system disorders other than at/rt that are inadequately controlled or may lead to discontinuation of the investigational drug
prognosis in patients with guillain-barre syndrome

Conditions: Guillain-Barre Syndrome

Summary: the goal of this observational study is to explore significant indicators to predict the early prognosis and late prognosis in patients with guillain-barre syndrome.

this is a multicenter study(approximately three) with over 450 subjects.clinical data were collected by consulting the patient's electronic history. the data included demographic information, blood biochemical markers, clinical characteristics and electromyography. all participants provided their written informed consent to participate in this study.

Eligibility criteria:
inclusion criteria: * patients fulfilled clinical, biological, and electrophysiology criteria for guillain-barre syndrome. exclusion criteria: * nonidiopathic guillain-barre syndrome and miller fisher syndrome

Keywords: guillain-barre syndrome
clinical and instrumental assessment of meniscal root tears treated through suture to the posterior cruciate ligament

Conditions: Meniscus Tear; Meniscus Lesion; Knee Injuries

Summary: the menisci are crucial for knee stability and functionality. composed of fibrocartilaginous structure, they have an anatomical and biomechanical arrangement that makes them essential for load transmission and the prevention of osteoarthritis. meniscal root lesions, known as "root tears," compromise their protective function on the cartilage, leading to increased contact pressures between the tibia and femur and, over time, the development of osteoarthritis. early diagnosis of these lesions is difficult and often the first detection is incidental. the subsequent challenges are significant due to a lack of pre-operative planning. a possible solution is a surgical technique involving arthroscopic suture of the posterior meniscal root along with the posterior cruciate ligament. this procedure does not require pre-operative planning and is applicable even in cases of incidental diagnosis.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 50 years at the time of surgery; 2. male and female gender; 3. patients undergoing surgical treatment for at least one year for "root" type meniscal lesions using arthroscopic suturing to the posterior cruciate ligament; 4. pre-operative mri performed. exclusion criteria: 1. patients no longer reachable; 2. patients who refuse consent to the study; 3. previous meniscectomy before surgery; 4. previous ligament injuries before surgery; 5. new traumatic injuries after surgery; 6. advanced knee osteoarthritis (outerbridge grade iii-iv) at the time of surgery; 7. severe knee malalignment (\> 5°) at the time of surgery; 8. severe obesity (bmi \> 35); 9. lower limb conditions preventing full weight-bearing during evaluation; 10. infection or hematological/rheumatic conditions at the time of evaluation.
disturbance of water and sodium metabolism after surgery of sellar lesions, and correspond clinical strategy

Conditions: The Patients Suffered With Sellar Diseases; The Fluid and Electrolyte Imbalance Happened After Surgery

Summary: the fluid and electrolyte imbalance (fei) is pretty common encountered during the clinical process of patients suffered sellar lesions. moreover, if the patients are undergone the surgery for remove the lesion, fei happens in all cases without exception. hypo- and hyper-natremia is the most common electrolyte disorder, which is directly correlated to the patients' outcome. however, in clinical works, different sellar diseases cause variant features of fei. for example, after the surgery of craniopharyngioma, the hyponatremia and hypernatremia always happen alternatively even without any precursor manifestation. under this situation, it is quite difficult for fluid supplement. in contrast, the severe fei will cause poor outcome, even death. so it is necessary to systematically collect and review the clinical data of sellar lesions. through the analysis of variant fei patterns of sellar diseases, more precise strategy for clinical fluid replacement will be proposed.


Eligibility criteria:
inclusion criteria: * 1. suffered with sellar disease * 2. udergone surgery * 3. have sufficient presurgical and postsurgical clinical data (including mri, ct, physical and chemical detection results) exclusion criteria: * 1. without sufficitent clincal data * 2. no surgery

Keywords: fluid and electrolyte imbalance hyponatremia hypernatremia electrolytes disorder
cannabinoids for pain control during medical abortion

Conditions: Medical Abortion; Pain

Summary: the objective of this study is to determine if a synthetic cannabis derivative, dronabinol, in addition to ibuprofen, decreases maximum pain scores compared to ibuprofen and placebo in women undergoing medical abortion. results of this study will help providers counsel patients regarding cannabis use during medical abortion.

this is a randomized, double-blind, placebo-controlled trial comparing pain levels in women undergoing medical abortion with one of two regimens: ibuprofen 800mg and a 5mg oral dronabinol versus ibuprofen 800mg and placebo given at the time of misoprostol administration. this study will include 62 women undergoing medical abortion. women will be randomized to dronabinol 5mg oral versus placebo. the primary outcome will be maximum reported pain score within 24 hours of misoprostol administration.

Eligibility criteria:
inclusion criteria: * aged 21 years or older * consented for elective medical abortion * pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound * able and willing to receive text messages via phone * english speaking * able and willing to give informed consent and agree to the study terms * have assistance at home; no motor vehicle use while taking study medications exclusion criteria: * desires to continue pregnancy or currently breastfeeding * lack of access to cell phone and texting capabilities * prior participation in this study * early pregnancy failure * contraindications to the study medications: marinol or marijuana derivatives, sesame oil, ibuprofen * contraindications to medical abortion with mifepristone or misoprostol * history of methadone, buprenorphine or heroin use within the last year * history of a seizure disorder * used marijuana 5 or more days in the last week * history of any adverse effects associated with prior use of recreational or medical marijuana products, or sensitivity/allergy to marinol.

Keywords: medical abortion pain cannabis
study to investigate the efficacy of a non-hormonal drug against endometriosis associated pelvic pain

Conditions: Endometriosis

Summary: this study was designed as a proof-of-concept trial to evaluate safety, tolerability, and the efficacy of 1800 mg (zk 811752 600 mg given orally three times daily) over 12 weeks for the treatment of endometriosis associated pelvic pain (eapp) in comparison to placebo.

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer schering pharma ag, germany. bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * pain associated with proven endometriosis, as determined by diagnostic measures within 24 months prior to start of treatment * women with cyclic menstrual bleeding- good general health * willingness to use a barrier contraceptive method such as condoms but no hormonal contraception- willingness to use only up to 3 ibuprofen 400 tablets as pain killer for endometriosis-related pelvic pain - age 18 to 45 years inclusive - fertile and non-fertile exclusion criteria: * pregnancy, lactation- bearing of an intra-uterine device * current use of hormonal agents. * actual or history of cardiovascular and further serious disorders

Keywords: endometriosis associated pelvic pain
cardiovascular events based on statin initiation in the elderly

Conditions: Cardiovascular; Dyslipidemia

Summary: the purpose of this study is to compare rates and risk of primary cardiovascular events among elderly patients newly initiating therapy with atorvastatin or simvastatin. the specific objectives for this project are to: 1) examine the demographic and clinical characteristics of the elderly patients in whom atorvastatin or simvastatin was newly initiated; and 2) compare cardiovascular event rates in elderly patients in whom atorvastatin or simvastatin was newly initiated.

all subjects meeting sample definition, all inclusion criteria, and none of the exclusion criteria.

Eligibility criteria:
inclusion criteria: * ≥ 1 fill for atorvastatin or simvastatin (not including combination therapy) between 01 july 2006 and 30 november 2008 * age ≥ 65 years as of the year of index date * continuous enrollment with medical and pharmacy benefits during the analytic period exclusion criteria: * 1 or more fills for a statin or other dyslipidemia medication in the 12-month pre-index period * a pharmacy fill for clopidogrel or nitrates (except concomitant hydralazine) in the 12-month pre-index period * patients with evidence of a cardiovascular event in the 12-month pre-index period. * patients who received both atorvastatin and simvastatin on the index date * patients with unknown gender or region * patients who received dyslipidemia medications other than the index drug within 1 months (30 days) following the index date

Keywords: dyslipidemia cardiovascular statin
perception of cohesion within a relationship (dyadic adjustment) on the quality of life of patients with prostate cancer with gonadotropin-releasing hormone.

Conditions: Prostate Cancer

Summary: the general hypothesis put forward in this study is that the degree of cohesion (agreement) in the relationship, or dyadic adjustment affects a patient's quality of life and clinical course during the first few critical months following diagnosis and the introduction of treatment. the level of cohesion in the relationship is certainly not the only parameter associated with changes in the quality of life. other factors must also be investigated such as level of education, circumstances surrounding the diagnosis (new diagnosis or relapse), management (single therapy or adjuvant therapy), the level of physical activity, the patient's age and the presence of functional disorders, etc.


Eligibility criteria:
inclusion criteria: * patient presenting with histologically confirmed prostate cancer. * patient eligible to start gnrh agonist therapy, either as monotherapy or adjuvant therapy, and for whom one of these treatments was selected voluntarily by the urologist, prior to the start of the study. * patient currently living with the same partner for at least 6 months. * patient and partner capable of reading, understanding and returning an evaluation self-questionnaire 6 months after the initial consultation. * patient giving its written consent to participate to the study. exclusion criteria: * the subject is participating in another clinical trial. * patient who has received a gnrh agonist therapy during the last 2 years.
a multi-site trial of ms inform (fatigue management resource)

Conditions: Multiple Sclerosis

Summary: people with ms commonly experience extreme fatigue that negatively impacts their ability to engage in a full range of daily activities, quality of life, and employment. a new website called ms inform (multiple sclerosis: an interactive fatigue management resource) allows people with ms to take a personalized and active approach to learning about and managing their fatigue. the aims of this study are: 1. to determine to determine whether 3-month use of the ms inform website can reduce the impact of fatigue on daily life among persons with ms. 2. to determine whether 3-month use of the ms inform website results in improvement in self- efficacy/ confidence for managing ms fatigue, self-reported cognitive function, participation and autonomy/ independence, and depression. 3. to determine whether benefits are maintained among the ms inform users after 6-months.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ms * between 18 and 65 years of age * access to a computer or other electronic device with internet access on which to use the website * report mild to moderate fatigue * live in canada exclusion criteria: * any major comorbid conditions that might influence fatigue management (lupus, rheumatoid arthritis, chronic obstructive lung disease, chronic fatigue syndrome) * report difficulty reading and comprehending english written at a grade 7 level * report upper extremity or visual impairments that cannot be accommodated adequately to enable computer access

Keywords: multiple sclerosis fatigue self-management rehabilitation
study to evaluate the efficacy and safety of oxabact (oc5) in primary hyperoxaluria patients who are on dialysis

Conditions: Primary Hyperoxaluria

Summary: the purpose of this study is to determine if oxalobacter formigenes is effective at lowering plasma oxalate levels in patients with primary hyperoxaluria who are on dialysis.


Eligibility criteria:
inclusion criteria: 1. signed informed consent (as applicable for the age of the subject). an appendix to the informed consent will be signed by patients continuing on treatment after week 14. 2. male or female subjects ≥ 2 years of age. subjects have to be able to swallow size 4 capsules twice daily for 6 weeks, or use a gastric tube that allows for administration of size 4 capsules. 3. a diagnosis of ph (as determined by standard diagnostic methods). 4. patient should be on a stable dialysis regimen for at least two weeks before baseline. 5. pre-dialysis plasma oxalate ≥40 micromole/l. 6. patients receiving vitamin b6 must be receiving a stable dose for at least 3 months prior to screening and must remain on the stable dose during the study. patients not receiving vitamin b6 at study entry must be willing to refrain from initiating vitamin b6 during study participation. exclusion criteria: 7. inability to swallow size 4 capsules twice daily for 6 weeks or using a gastric tube not suited for administration of size 4 capsules via the tube. 8. ongoing treatment with immunosuppressive medication. 9. the existence of secondary hyperoxaluria, e.g. hyperoxaluria due to bariatric surgery or chronic gastrointestinal diseases such as cystic fibrosis, chronic inflammatory bowel disease and short-bowel syndrome. 10. use of antibiotics to which o. formigenes is sensitive, including current antibiotic use, or antibiotics use within 14 days of initiating study medication. 11. current treatment with a separate ascorbic acid preparation. standard of care vitamin supplement for patients on dialysis is allowed. 12. pregnancy. 13. women of childbearing potential who are not using adequate contraceptive precautions. sexually active females, unless surgically sterile or at least 2 years post-menopausal, must be using a highly effective contraception (including oral, transdermal, injectable, or implanted contraceptives, iud, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of oc5 and must agree to continue using such precautions during the clinical study. 14. presence of a medical condition that the investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures. 15. participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to the first dose of oc5 or not willing to forego other forms of investigational treatment during this study.

Keywords: hyperoxaluria oxalate ph dialysis